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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00085839 |
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Date of registration:
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15/06/2004 |
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Primary sponsor: |
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Public title:
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Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
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Scientific title:
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A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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103 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00085839 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
- No prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2
- Clinically or radiologically measurable disease per RECIST criteria
Exclusion Criteria:
- Gastro-intestinal abnormalities
- Any concurrent anticancer therapy
- Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
- Other active malignancies
- Uncontrolled brain metastases
- Severe abnormalities of the cornea
- Significant cardiac disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Small Cell Lung Cancer
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Intervention(s)
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Drug: Combination carboplatin and paclitaxel
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Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
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Primary Outcome(s)
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Progression-free Survival
[Time Frame: Until time of disease progression (maximum 5 months)]
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Secondary Outcome(s)
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Best Tumor Response
[Time Frame: While receiving study treatment (maximum 60 weeks)]
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Overall Survival
[Time Frame: From first study treatment until time of death (maximum 26.8 months)]
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Secondary ID(s)
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OSI-774-201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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